validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, January 1, 2018
Writing Validation Requests and Validation Plans
At IVT's 4th Annual Validation Week EU, Paul Pluta, Ph.D., explains the process of connecting Stage 1 and Stage 2 of process validation through properly written and well formed validation requests and validation plans. Dr. Pluta discusses the role of R&D in the document's development and demonstrates utilizing these documents for FDA compliance. Comprehensive outlines for both documents are examined.
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